Effect of an HPV Vaccination Multi-Level, Multi-Component Program on HPV Vaccination Initiation and Completion in a Pediatric Clinic Network.

Despite clear evidence of the public health benefits of the human papillomavirus (HPV) vaccine in preventing HPV-related cancers and genital warts, underutilization of HPV vaccination in the United States persists. Interventions targeting multi-level determinants of vaccination behavior are crucial for improving HPV vaccination rates. The study's purpose was to implement and evaluate the adapted Adolescent Vaccination Program (AVP), a clinic-based, multi-level, multi-component intervention aimed at increasing HPV vaccine initiation and completion rates in a five-clinic pediatric network in Bexar County, Texas. The adaptation process was guided by established frameworks and involved formative work with clinic stakeholders. The study utilized a quasi-experimental single group pre- and post- study design, with an external comparison data using the National Immunization Survey-Teen (NIS-Teen) datasets for the same time period to examine the AVP's effect on HPV vaccination initiation and completion. A series of interrupted time series analyses (ITSA) compared the clinic system patient outcomes (HPV vaccination initiation and completion rates) in the post-intervention to the general adolescent population (NIS-Teen). Of the 6438 patients (11-17 years) with clinic visits during the 3-year study period, HPV vaccination initiation rates increased from 64.7% to 80.2% (p < 0.05) and completion rates increased from 43.2% to 60.2% (p < 0.05). The AVP was effective across various demographic and economic subgroups, demonstrating its generalizability. ITSA findings indicated the AVP improved HPV vaccination initiation and completion rates in clinic settings and that AVP strategies facilitated resilience during the pandemic. The minimal adaptation required for implementation in a new clinic system underscores its feasibility and potential for widespread adoption.

AVPCancerFree: Impact of a digital behavior change intervention on parental HPV vaccine -related perceptions and behaviors.

Parent hesitancy contributes to reduced HPV vaccination rates. The HPVcancerfree app (HPVCF) was designed to assist parents in making evidence-based decisions regarding HPV vaccination. This study examined if parents of vaccine-eligible youth (11-12 yrs.) who use HPVCF in addition to usual care demonstrate significantly more positive intentions and attitudes toward HPV vaccination and greater HPV vaccination rates compared to those not using HPVCF. Clinics (n = 51) within a large urban pediatric network were randomly assigned to treatment (HPVCF + usual care) or comparison (usual care only) conditions in a RCT conducted between September 2017 and February 2019. Parents completed baseline and 5-month follow-up surveys. Participant-level analysis determined 1) change in HPV vaccination initiation behavior and related psychosocial determinants and 2) predictors of HPV vaccine initiation. Parents (n = 375) who completed baseline and 5-month follow-up surveys were female (95.2%), 40.8 (±5.8) yrs. married (83.7%), employed (68.3%), college educated (61.9%), and privately insured (76.5%). Between-group analysis of HPVCF efficacy demonstrated that parents assigned to receive HPVCF significantly increased knowledge about HPV and HPV vaccination (p < .05). Parents who accessed content within HPVCF significantly increased knowledge about HPV & HPV vaccine (p < .01) and perceived effectiveness of HPV vaccine (p < .05). Change in HPV vaccine initiation was not significant. A multivariate model to describe predictors of HPV vaccine initiation demonstrated an association with Tdap and MCV vaccination adoption, positive change in perceived effectiveness of the HPV vaccine, and reduction in perceived barriers against HPV vaccination. HPVCF appears to be a feasible adjunct to the education received in usual care visits and reinforces the value of apps to support the important persuasive voice of the health-care provider in overcoming parent HPV vaccine hesitancy.

Parents' Experience With a Mobile Health Intervention to Influence Human Papillomavirus Vaccination Decision Making: Mixed Methods Study.

BACKGROUND: Human papillomavirus (HPV)-attributed cancers are preventable, yet HPV vaccination rates severely lag behind other adolescent vaccinations. HPVcancerFree (HPVCF) is a mobile health (mHealth) intervention developed to influence parental HPV vaccination decision making by raising awareness of HPV, reducing HPV vaccination barriers, and enabling HPV vaccination scheduling and reminders through a smartphone app. Evaluating the user experience of mHealth interventions is a vital component in assessing their quality and success but tends to be underreported in mHealth intervention evaluation. OBJECTIVE: We aimed to evaluate the user experience of HPVCF, an HPV cancer prevention app designed for a pediatric clinic network, using mixed methods data collected from log files, survey measures, and qualitative feedback. METHODS: Study data were evaluated from parents in a large US pediatric clinic network using HPVCF in the treatment study condition of a group randomized controlled trial. Log data captured HPVCF retention and use. Postintervention rating scales and items assessed HPVCF utility, usefulness, understandability, appeal, credibility, and perceived impact. Overall quality was evaluated using the user version of the Mobile Application Rating Scale (uMars). Open-ended responses assessed parent recommendations for HPVCF enhancement. RESULTS: The 98 parents were mainly female (n=94, 96%), 41 (5.67) years of age, college educated (n=55, 56%), and White and non-Hispanic (n=55, 56%) and had private health insurance for their children (n=75, 77%). Parents used HPVCF 197 times, with the average visit duration approximating 3.5 minutes. The uMARS app quality score was positively skewed (4.2/5.0). Mean ratings were highest for information (4.46 [SD 0.53]) and lowest for engagement (3.74 [SD 0.69]). In addition, of 95 parents, 45 (47%) rated HPVCF as helpful in HPV vaccination decision making and 16 (17%) attributed HPV vaccine initiation to HPVCF. Parents reported that HPVCF increased their awareness (84/95, 88%), knowledge (84/95, 88%), and HPV vaccination intentions (64/95, 67%). Most of the 98 parents rated the 4 HPVCF components as useful (72-92 [73%-94%]). Parents also agreed that HPVCF is clear (86/95, 91%), accurate (86/95, 91%), and more helpful than other HPV vaccine information they had received (89/95, 94%) and that they would recommend it to others (81/95, 85%). In addition, parents suggested ways to increase awareness and engagement with the app, along with opportunities to enhance the content and functionality. CONCLUSIONS: HPVCF was well received by parents and performed well on indicators of quality, usefulness, utility, credibility, and perceived impact. This study contributes a multimethod and multimeasure evaluation to the growing body of literature focused on assessing the user experience of patient-focused technology-mediated applications for HPV education.

A stepped randomized trial to promote colorectal cancer screening in a nationwide sample of U.S. Veterans.

BACKGROUND: Colorectal cancer (CRC) screening (CRCS) facilitates early detection and lowers CRC mortality. OBJECTIVES: To increase CRCS in a randomized trial of stepped interventions. Step 1 compared three modes of delivery of theory-informed minimal cue interventions. Step 2 was designed to more intensively engage those not completing CRCS after Step 1. METHODS: Recruitment packets (60,332) were mailed to a random sample of individuals with a record of U.S. military service during the Vietnam-era. Respondents not up-to-date with CRCS were randomized to one of four Step 1 groups: automated telephone, telephone, letter, or survey-only control. Those not completing screening after Step 1 were randomized to one of three Step 2 groups: automated motivational interviewing (MI) call, counselor-delivered MI call, or Step 2 control. Intention-to-treat (ITT) analyses assessed CRCS on follow-up surveys mailed after each step. RESULTS: After Step 1 (n = 1784), CRCS was higher in the letter, telephone, and automated telephone groups (by 1%, 5%, 7%) than in survey-only controls (43%), although differences were not statistically significant. After Step 2 (n = 516), there were nonsignificant increases in CRCS in the two intervention groups compared with the controls. CRCS following any combination of stepped interventions overall was 7% higher (P = 0.024) than in survey-only controls (55.6%). CONCLUSIONS: In a nationwide study of Veterans, CRCS after each of two stepped interventions of varying modes of delivery did not differ significantly from that in controls. However, combined overall, the sequence of stepped interventions significantly increased CRCS.

Association of physicians perceived barriers with human papillomavirus vaccination initiation.

Physician recommendation is a strong predictor of vaccine uptake, however their perceived barriers may prevent vaccination. Therefore, we determined the association between physicians' perceived barriers to HPV vaccination and vaccination initiation. We surveyed pediatricians in a large network of clinics in Houston, Texas to assess their perceived barriers to vaccinating adolescents. We combined survey data with electronic medical records to determine HPV vaccination initiation over a 12-month study period (July 2014-June 2015). Patients were 11-18year olds who had not begun the vaccination series, had a physician visit during the study period, and whose physician completed the survey. We conducted a multilevel model clustered by physician controlling for patient and physician demographics to calculate the association between physician-reported barriers and HPV vaccination initiation. Among 36,827 patients seen by 134 pediatricians, 18.6% initiated HPV vaccination. The relative risk of initiating HPV vaccination were lower for patients whose physician reported concerns about HPV vaccine safety (RR: 0.75, 95% CI: 0.58-0.97), efficacy (RR: 0.73, 95% CI: 0.54-0.99), and the financial burden of the vaccine on patients (RR: 0.72, 95% CI: 0.58-0.88). After controlling for patient and physician characteristics, physician concern about the financial burden on patients was significantly associated with lower relative risk of initiating HPV vaccination (RR: 0.76, 95% CI: 0.64-0.90). In this large study we observed that physician-reported barriers are associated with HPV vaccination initiation. Interventions should be implemented to educate physicians on vaccine safety, efficacy, and that there is no patient cost for CDC-recommended vaccines.

Impact of Booster Breaks and Computer Prompts on Physical Activity and Sedentary Behavior Among Desk-Based Workers: A Cluster-Randomized Controlled Trial.

INTRODUCTION: The 15-minute work break provides an opportunity to promote health, yet few studies have examined this part of the workday. We studied physical activity and sedentary behavior among office workers and compared the results of the Booster Break program with those of a second intervention and a control group to determine whether the Booster Break program improved physical and behavioral health outcomes. METHODS: We conducted a 3-arm, cluster-randomized controlled trial at 4 worksites in Texas from 2010 through 2013 to compare a group-based, structured Booster Break program to an individual-based computer-prompt intervention and a usual-break control group; we analyzed physiologic, behavioral, and employee measures such as work social support, quality of life, and perceived stress. We also identified consistent and inconsistent attendees of the Booster Break sessions. RESULTS: We obtained data from 175 participants (mean age, 43 y; 67% racial/ethnic minority). Compared with the other groups, the consistent Booster Break attendees had greater weekly pedometer counts (P < .001), significant decreases in sedentary behavior and self-reported leisure-time physical activity (P < .001), and a significant increase in triglyceride concentrations (P = .02) (levels remained within the normal range). Usual-break participants significantly increased their body mass index, whereas Booster Break participants maintained body mass index status during the 6 months. Overall, Booster Break participants were 6.8 and 4.3 times more likely to have decreases in BMI and weekend sedentary time, respectively, than usual-break participants. CONCLUSION: Findings varied among the 3 study groups; however, results indicate the potential for consistent attendees of the Booster Break intervention to achieve significant, positive changes related to physical activity, sedentary behavior, and body mass index.

Correlates of self-reported colorectal cancer screening accuracy in a multi-specialty medical group practice.

PURPOSE: We assessed whether accuracy of self-reported screening for colorectal cancer (CRC) varied by respondent characteristics or healthcare utilization. METHODS: From 2005 to 2007, 857 respondents aged 51 - 74 were recruited from a multi-specialty medical group practice to answer a questionnaire about their CRC screening (CRCS) behaviors. Self-reports were compared with administrative and medical records to assess concordance, sensitivity, specificity, and report-to-records ratios for overall CRCS (fecal occult blood test, sigmoidoscopy, and/or colonoscopy). RESULTS: Concordance was good (≥0.8 to <0.9) or fair (≥0.7 to <0.8) for most subgroups; respondents with >5 visits outside the clinic had poor (<0.7) concordance. Sensitivity estimates were mostly excellent (≥0.9) or good but poor for respondents whose healthcare provider did not advise a specific CRCS test. Specificity was poor for the following respondents: 65+ years, males, college graduates, family history of CRC, >5 visits outside of the clinic, or whose healthcare provider advised a specific CRCS test. Respondents 65+ years and with >5 outside visits over-reported CRCS. CONCLUSIONS: With few exceptions, self-reports of CRCS in an insured population is reasonably accurate across subgroups. More work is needed to replicate these findings in diverse settings and populations to better understand subgroup differences and improve measures of CRCS.

Factorial validity and invariance of four psychosocial constructs of colorectal cancer screening: does screening experience matter?

BACKGROUND: Few studies have examined the psychometric properties and invariance of scales measuring constructs relevant to colorectal cancer screening (CRCS). We sought to: (i) evaluate the factorial validity of four core constructs associated with CRCS (benefits, barriers, self-efficacy, and optimism); and (ii) examine measurement invariance by screening status (currently screened, overdue, never screened). METHODS: We used baseline survey data from a longitudinal behavioral intervention trial to increase CRCS among U.S. veterans. Respondents were classified as currently screened (n = 3,498), overdue (n = 418), and never screened (n = 1,277). The measurement model was developed using a random half of the sample and then validated with the second half of the sample and the full baseline sample (n = 5,193). Single- and multi-group confirmatory factor analysis was used to examine measurement invariance by screening status. RESULTS: The four-factor measurement model demonstrated good fit. Factor loadings, item intercepts, and residual item variance and covariance were invariant when comparing participants never screened and overdue for CRCS, indicating strict measurement invariance. All factor loadings were invariant among the currently screened and overdue groups. Only the benefits scale was invariant across current screeners and never screeners. Non-invariant items were primarily from the barriers scale. CONCLUSION: Our findings provide additional support for the construct validity of scales of CRCS benefits, barriers, self-efficacy, and optimism. A greater understanding of the differences between current and never screeners may improve measurement invariance. IMPACT: Measures of benefits, barriers, self-efficacy, and optimism may be used to specify intervention targets and effectively assess change pre- and post-intervention across screening groups.

Are cancer registries a viable tool for cancer survivor outreach? A feasibility study.

PURPOSE: Little is known about cancer survivors' receptivity to being contacted through cancer registries for research and health promotion efforts. We sought to (1) determine breast and colorectal cancer (CRC) survivors' responsiveness to a mailed survey using an academic medical center's cancer registry, (2) assess whether responsiveness varied according to sociodemographic characteristics and medical history, and (3) examine the prevalence and correlates of respondents' awareness and willingness to be contacted through the state cancer registry for future research studies. METHODS: Stage 0-III breast and CRC survivors diagnosed between January 2004 and December 2009 were identified from an academic medical center cancer registry. Survivors were mailed an invitation letter with an opt-out option, along with a survey assessing sociodemographic characteristics, medical history, and follow-up cancer care access and utilization. RESULTS: A total of 452 (31.4 %) breast and 53 (22.2 %) CRC survivors responded. Willingness to be contacted through the state cancer registry was high among both breast (74 %) and CRC (64 %) respondents even though few were aware of the registry and even fewer knew that their information was in the registry. In multivariable analyses, tumor stage I and not having a family history of cancer were associated with willingness among breast and CRC survivors, respectively. CONCLUSIONS: Our findings support the use of state cancer registries to contact survivors for participation in research studies. IMPLICATIONS FOR CANCER SURVIVORS: Survivors would benefit from partnerships between researchers and cancer registries that are focused on health promotion interventions.

Is the accuracy of self-reported colorectal cancer screening associated with social desirability?

BACKGROUND: Self-reported cancer screening behaviors are often overreported and may lead to biased estimates of prevalence and of subgroup differences in screening. We examined whether the tendency to give socially desirable responses was associated with concordance between self-reported colorectal cancer (CRC) screening behaviors and medical records. METHODS: Primary care patients (n = 857) age 50 to 74 years completed a mail, face-to-face, or telephone survey that assessed CRC screening and social desirability measured by a short version of the Marlowe-Crowne scale. We used medical records to verify self-reports of fecal occult blood testing (FOBT), sigmoidoscopy, colonoscopy, and barium enema. RESULTS: Social desirability scores were lower for whites versus African Americans, college graduates, and patients reporting no prior screening tests; they were higher for telephone versus mail or face-to-face survey respondents. In univariable logistic regression analysis, social desirability scores were not associated with concordance for FOBT (OR = 1.03, 95% CI = 0.94-1.13), sigmoidoscopy (OR = 0.95, 95% CI = 0.86-1.04), or colonoscopy (OR = 0.99, 95% CI = 0.88-1.11); however, lower social desirability scores were associated with increased concordance for barium enema (OR = 0.87, 95% CI = 0.77-0.99). In multivariable analyses, no associations were statistically significant. CONCLUSION: Social desirability as measured by the Marlowe-Crowne scale was not associated with accuracy of self-reported CRC tests in our sample, suggesting that other explanations for overreporting need to be explored. IMPACT: By understanding sources of response bias, we can improve the accuracy of self-report measures.

Preferences for colorectal cancer screening tests and screening test use in a large multispecialty primary care practice.

BACKGROUND: The purpose of this study was to identify factors associated with colorectal cancer (CRC) screening test preference and examine the association between test preference and test completed. METHODS: Patients (n = 1224) were 50-70 years, at average CRC risk, and overdue for screening. Outcome variables were preference for fecal occult blood test (FOBT), colonoscopy (COL), sigmoidoscopy (SIG), or barium enema (BE), measured by telephone survey, and concordance between test preference and test completed assessed using medical records. RESULTS: Thirty-five percent preferred FOBT, 41.1% COL, 12.7% SIG, and 5.7% BE. Preference for SIG or COL was associated with having a physician recommendation, greater screening readiness, test-specific self-efficacy, greater CRC worry, and perceived pros of screening. Preference for FOBT was associated with self-efficacy for doing FOBT. Participants who preferred COL were more likely to complete COL compared with those who preferred another test. Of those screened, only 50% received their preferred test. Those not receiving their preferred test most often received COL (52%). CONCLUSIONS: Lack of concordance between patient preference and test completed suggests that patients' preferences are not well incorporated into screening discussions and test decisions, which could contribute to low screening uptake. Physicians should acknowledge patients' preferences when discussing test options and making recommendations, which may increase patients' receptivity to screening.

A randomized controlled trial of a tailored interactive computer-delivered intervention to promote colorectal cancer screening: sometimes more is just the same.

BACKGROUND: There have been few studies of tailored interventions to promote colorectal cancer (CRC) screening. PURPOSE: We conducted a randomized trial of a tailored, interactive intervention to increase CRC screening. METHODS: Patients 50-70 years completed a baseline survey, were randomized to one of three groups, and attended a wellness exam after being exposed to a tailored intervention about CRC screening (tailored group), a public web site about CRC screening (web site group), or no intervention (survey-only group). The primary outcome was completion of any recommended CRC screening by 6 months. RESULTS: There was no statistically significant difference in screening by 6 months: 30%, 31%, and 28% of the survey-only, web site, and tailored groups were screened. Exposure to the tailored intervention was associated with increased knowledge and CRC screening self-efficacy at 2 weeks and 6 months. Family history, prior screening, stage of change, and physician recommendation moderated the intervention effects. CONCLUSIONS: A tailored intervention was not more effective at increasing screening than a public web site or only being surveyed.

Accuracy of self-reported reason for colorectal cancer testing.

Assessment of accuracy of self-reported reason for colorectal cancer testing has been limited. We examined the accuracy and correlates of self-reported reason (screening or diagnosis) for having a sigmoidoscopy or colonoscopy. Patients who had received at least one sigmoidoscopy or colonoscopy within the past 5 years were recruited from a large multispecialty clinic in Houston, TX, between 2005 and 2007. We calculated concordance, positive predictive value, negative predictive value, sensitivity, and specificity between self-reported reason and the medical record (gold standard). Logistic regression was performed to identify correlates of accurate self-report. Self-reported reason for testing was more accurate when the sigmoidoscopy or colonoscopy was done for screening, rather than diagnosis. In the multivariable analysis for sigmoidoscopy, age was positively associated with accurately reporting reason for testing, whereas having two or more colorectal cancer tests during the study period (compared with only one test) was negatively associated with accuracy. In the multivariable analysis, none of the correlates was statistically associated with colonoscopy although a similar pattern was observed for number of tests. Determining the best way to identify those who have been tested for diagnosis, rather than screening, is an important next step.

Promoting regular mammography screening I. A systematic assessment of validity in a randomized trial.

BACKGROUND: Most health promotion trials in cancer screening offer limited evidence of external validity. We assessed internal and external validity in a nationwide, population-based trial of an intervention to promote regular mammography screening. METHODS: Beginning in September 2000, study candidates age 52 years and older (n = 23,000) were randomly selected from the National Registry of Women Veterans and sent an eligibility survey. Consistent with intention-to-treat principles for effectiveness trials, we randomly assigned eligible respondents and nonrespondents to one of five groups. We mailed baseline surveys to groups 1-3 followed by intervention materials of varying personalization to groups 1 and 2. We delayed mailing baseline surveys to two additional control groups to coincide with the mailing of postintervention follow-up surveys to groups 1-3 at year 1 (group 4) and year 2 (group 5). Mammography rates were determined from self-report and Veterans Health Administration records. To assess internal validity, we compared groups on participation and factors associated with mammography screening at each stage. To assess external validity, we compared groups 3, 4, and 5 on mammography rates at the most recent follow-up to detect any cueing effects of prior surveys and at the respective baselines to uncover any secular trends. We also compared nonparticipants with participants on factors associated with mammography screening at the trial's end. RESULTS: We established study eligibility for 21,340 (92.8%) of the study candidates. Groups 1-3 were similar throughout the trial in participation and correlates of mammography screening. No statistically significant survey cueing effects or differences between nonparticipants and participants across groups were observed. Mammography screening rates over the 30 months preceding the respective baselines were lower in group 5 (82.3% by self-report) than in groups 1-4 (85.1%, P = .024, group 5 vs groups 1-4 combined), suggesting a decline over time similar to that reported for US women in general. CONCLUSION: This systematic assessment provides evidence of the trial's internal and external validity and illustrates an approach to evaluating validity that is readily adaptable to future trials of behavioral interventions.

Promoting regular mammography screening II. Results from a randomized controlled trial in US women veterans.

BACKGROUND: Few health promotion trials have evaluated strategies to increase regular mammography screening. We conducted a randomized controlled trial of two theory-based interventions in a population-based, nationally representative sample of women veterans. METHODS: Study candidates 52 years and older were randomly sampled from the National Registry of Women Veterans and randomly assigned to three groups. Groups 1 and 2 received interventions that varied in the extent of personalization (tailored and targeted vs targeted-only, respectively); group 3 was a survey-only control group. Postintervention follow-up surveys were mailed to all women after 1 and 2 years. Outcome measures were self-reported mammography coverage (completion of one postintervention mammogram) and compliance (completion of two postintervention mammograms). In decreasingly conservative analyses (intention-to-treat [ITT], modified intention-to-treat [MITT], and per-protocol [PP]), we examined crude coverage and compliance estimates and adjusted for covariates and variable follow-up time across study groups using Cox proportional hazards regression. For the PP analyses, we also used logistic regression. RESULTS: None of the among-group differences in the crude incidence estimates for mammography coverage was statistically significant in ITT, MITT, or PP analyses. Crude estimates of compliance differed at statistically significant levels in the PP analyses and at levels approaching statistical significance in the ITT and MITT analyses. Absolute differences favoring the intervention over the control groups were 1%-3% for ITT analysis, 1%-5% for MITT analysis, and 2%-6% for the PP analysis. Results from Cox modeling showed no statistically significant effect of the interventions on coverage or compliance in the ITT, MITT, or PP analyses, although hazard rate ratios (HRRs) for coverage were consistently slightly higher in the intervention groups than the control group (range for HRRs = 1.05-1.09). A PP analysis using logistic regression produced odds ratios (ORs) that were consistently higher than the corresponding hazard rate ratios for both coverage and compliance (range for ORs = 1.15-1.29). CONCLUSIONS: In none of our primary analyses did the tailored and targeted intervention result in higher mammography rates than the targeted-only intervention, and there was limited support for either intervention being more effective than the baseline survey alone. We found that adjustment for variable follow-up time produced more conservative (less favorable) intervention effect estimates.